An ultrasonic endoscope and a tip portion thereof

Abstract

The application provides an ultrasonic endoscope and a head end thereof, comprising a head end seat and an ultrasonic probe, the head end seat has a proximal end and a distal end in a first direction, the distal end has a top and a bottom in a second direction, the distal end is formed with a guide groove, the guide groove has a groove end away from the proximal end and forming a guide exit at the top; the sound window of the ultrasonic probe has a base end side, in the second direction, from the distal end side of the distal end to the base end side of the sound window, there is a first feature part farthest from the bottom; the distal end side of the proximal end has a second feature part farthest from the bottom; in a projection plane parallel to the first direction and parallel to the second direction, there is a distance between the connecting line between the first feature part and the second feature part and the groove end. The application can avoid the ultrasonic probe sound window from being away from the object to be detected due to the sheath tube on the guide groove adhering to the object to be detected during the puncture operation, and can make the ultrasonic probe stably adhere to the object to be detected.

Description

Technical Field

[0001] This invention relates to the field of endoscopy technology, and more specifically, to an ultrasonic endoscope and its tip. Background Technology

[0002] Endoscopic imaging, as a non-invasive imaging method, can effectively extend the human field of vision and is widely used in imaging diagnosis and image-guided treatment in many fields such as the digestive tract, urinary system and respiratory system, greatly improving the accuracy of disease examination.

[0003] The part of an endoscope that enters the body is a long, narrow insertion section. The distal end of this section can form a tip. The insertion section typically has an instrument channel extending to the tip. During endoscopic diagnosis or treatment, medical instruments are inserted into this channel and protrude from the tip. An endoscopic ultrasound (EUS) is an endoscope equipped with ultrasound imaging capabilities. An ultrasound probe is placed at the tip of the endoscope for ultrasound diagnosis of tissues within cavities. Guided by the ultrasound image, a puncture needle can be extended through the instrument channel to perform biopsies and obtain information about deeper lesions.

[0004] However, in practical applications, it has been found that in some scenarios, especially when ultrasound images are acquired using the base side region of the ultrasound probe's acoustic window, the ultrasound probe is prone to instability in its contact with the wall during the puncture procedure. This has a significant impact on the ultrasound probe's detection and increases the difficulty of the puncture procedure. Summary of the Invention

[0005] In order to at least partially solve the problems existing in the prior art, according to one aspect of the present invention, a head end of an ultrasonic endoscope is provided, the technical solution of which is as follows.

[0006] The head end includes a head base and an ultrasound probe. The head base has a proximal end and a distal end in a first direction, which is the axial direction of the head base. The distal end has a top and a bottom along a second direction, which is perpendicular to the second direction. The distal end has a guide groove for discharging a medical device. The guide groove has a groove end that is away from the proximal end and forms an outlet at the top. The ultrasound probe is connected to the distal side of the distal end. The ultrasound probe has an acoustic window that has a base end near the distal end. From the distal end to the base end of the acoustic window, in the second direction, there is a first feature portion that is furthest from the bottom. The first feature portion is further away from the bottom than the groove end. In the second direction, the distal side of the proximal end has a second feature portion that is furthest from the bottom. The distance between the second feature portion and the bottom is not less than the distance between the first feature portion and the bottom. On a projection plane parallel to both the first and second directions, there is a gap between the line connecting the first and second feature portions and the groove end, with a gap of 0.5 mm to 2 mm.

[0007] The proximal end of the present invention has a guide groove formed at its distal end, which guides the extension of the medical device. From the distal end to the base of the acoustic window, there is a first feature portion furthest from the bottom in a second direction. This first feature portion is further away from the bottom than the end of the groove, thus creating a gap between the first feature portion and the end of the groove. In the second direction, the distal end of the proximal end has a second feature portion furthest from the bottom, and the distance between the second feature portion and the bottom is not less than the distance between the first feature portion and the bottom. Therefore, on a projection plane parallel to both the first and second directions, there is a gap between the line connecting the first and second feature portions and the end of the groove. Thus, when the base of the acoustic window of the ultrasound probe is against the subject, for example, against the bronchial wall, the line connecting the first and second feature portions and the guide groove are spaced apart. The spacing between the ends of the guide grooves provides space to accommodate the distal end of the medical device extending to the end of the groove. For example, during a puncture procedure, it provides space to accommodate the distal end of the sheath. This prevents the acoustic window of the ultrasound probe from moving away from the subject when the medical device (sheath) on the guide groove is in contact with the subject. This allows the ultrasound probe to be stably attached to the subject, resulting in better detection performance. A spacing of 0.5mm to 2mm can accommodate most sheath sizes. For example, the diameter of a sheath is usually no more than 1.8mm, so this spacing can accommodate most sheaths. Moreover, with this spacing, not only is the space sufficient to accommodate the sheath extending to the end of the groove, but the ultrasound probe will not obstruct the extension of the puncture needle.

[0008] For example, there is a gap between the end of the groove and the ultrasonic probe along the first direction. When there is a gap between the end of the groove and the ultrasonic probe along the first direction, it is not necessary to increase the deflection angle of the puncture needle to avoid the base side of the acoustic window, that is, to avoid the ultrasonic probe. This makes it easier for the puncture needle mounted on the guide groove to extend into the detection area of ​​the ultrasonic probe and to maintain a better puncture angle and puncture depth.

[0009] For example, the first feature is the base side of the acoustic window. This means that in the portion of the ultrasound probe located between the base side and the distal end of the acoustic window, there can be no other unnecessary parts besides the necessary connecting structures. In other words, the base side of the acoustic window can be placed as close to the distal end as possible on the ultrasound probe, thus making full use of the structural space along the first direction on the ultrasound probe, reducing space waste, and making the overall structure more compact.

[0010] For example, the head end also includes a camera module, which is disposed on the connecting surface on the proximal side connecting the second feature portion and the distal end portion, with the end of the groove located within the field of view of the camera module. The fact that the end of the groove is within the field of view of the camera module makes it easier to observe and determine the position of the medical device, thereby facilitating subsequent operations.

[0011] For example, in the second direction, the distance between the second feature and the bottom is greater than the distance between the first feature and the bottom. That is, the second feature is farther away from the bottom than the first feature, which makes it easier to place the camera module at a position farther away from the bottom, reducing the obstruction of the imaging field of the camera module by the ultrasonic probe.

[0012] For example, the medical device includes a sheath and a puncture needle inserted within the sheath; a mark is provided on the top of the device next to the guide groove, located within the field of view of the camera module, to indicate the recommended exit position of the puncture needle. When the distal end of the sheath extends to this recommended exit position, it will not come into contact with the subject, and after the puncture needle extends from the sheath at this recommended exit position, it can enter the detection area of ​​the ultrasound probe without interference. Thus, by providing a mark to indicate the recommended exit position of the puncture needle, it is possible to further prevent the sheath from coming into contact with the subject and to improve the convenience of the puncture operation.

[0013] For example, the markings are arranged in pairs, with one pair of markings symmetrically positioned about the guide groove. When a pair of markings are symmetrically positioned on both sides of the guide groove, they are more conspicuous, and the markings provide better indication of the relative position of the medical device. In addition, such a tip is also more suitable for medical devices with asymmetrical structures, thus broadening the applicability of the tip.

[0014] For example, the mark and the second feature have a first distance L1 in the first direction, and the base end of the acoustic window and the second feature have a second distance L2 in the first direction, the first distance L1 and the second distance L2 satisfying The first distance L1 and the second distance L2 satisfy... At the same time, the marker is a certain distance from the proximal end and also a certain distance from the base of the acoustic window. With the marker indicating a good effect, the recommended exit position indicated by such a marker can not only avoid the ultrasound probe from blocking the further extension of the medical device after it has been exited at the recommended exit position, but also further ensure that the medical device will not touch the subject when it is exited at the recommended exit position.

[0015] For example, the mark and the second feature have a first distance L1 in the first direction, where the first distance L1 is 2mm to 6mm. When the first distance L1 is 2mm to 6mm, the mark can promptly indicate the relative position of the medical device, making it easier to keep the medical device contained in the gap between the base side of the acoustic window and the end of the groove along the second direction during operation, thereby better preventing the medical device from touching the test subject.

[0016] According to another aspect of the present invention, an ultrasonic endoscope is provided. The ultrasonic endoscope includes an insertion portion, which includes any of the tip portions described above. Since the tip portions described above have the aforementioned beneficial effects, the ultrasonic endoscope including the tip portions described above also has the aforementioned beneficial effects, which will not be elaborated further here.

[0017] A series of simplified concepts are introduced in the description of the invention, which will be further explained in detail in the detailed description section. This description is not intended to limit the key features and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.

[0018] The advantages and features of the present invention will be described in detail below with reference to the accompanying drawings. Attached Figure Description

[0019] The following figures are included as part of this invention for understanding its principles. The figures illustrate embodiments of the invention and their descriptions, serving to explain the principles of the invention. In the figures,

[0020] Figure 1 This is a schematic diagram of the structure of an ultrasonic endoscope according to an exemplary embodiment of the present invention;

[0021] Figure 2 This is a cross-sectional view of a portion of the insertion section according to an exemplary embodiment of the present invention, wherein a medical device is mounted on the guide groove;

[0022] Figure 3 This is a perspective view of a portion of the structure of the insertion part according to an exemplary embodiment of the present invention;

[0023] Figure 4 for Figure 3 A top view of a portion of the structure in the insertion section shown;

[0024] Figure 5 for Figure 3 The side view of a portion of the structure in the insertion section is shown;

[0025] Figure 6 This is a side view of a portion of the structure in the insertion section according to an exemplary embodiment of the present invention;

[0026] Figure 7 This is a perspective view of a portion of the structure of an insertion part according to an exemplary embodiment of the present invention, wherein a medical device is mounted on a guide groove; and

[0027] Figure 8 for Figure 7 A top view of a portion of the structure in the insertion section shown.

[0028] The above figures include the following reference numerals:

[0029] 1. Ultrasonic endoscope; 10. Insertion section; 11. Head end; 111. Head end seat; 1111. Proximal end; 1111a. Second feature section; 1111b. Illumination module; 1111c. Camera module; 1111d. Connecting surface; 1112. Distal end; 1112a. Proximal side; 1112b. Distal side; 1113. Top; 1114. Bottom; 1115. Guide groove; 1115a. Groove end; 1116. Mark; 112. Ultrasonic probe; 1121. Acoustic window; 1122. Base side; 1123. Protrusion; 12. Bend; 13. Insertion tube; 14. Instrument channel; 20. Operating section; 30. Medical device; 31. Sheath; 32. Puncture needle. Detailed Implementation

[0030] In the following description, numerous details are provided to enable a thorough understanding of the invention. However, those skilled in the art will appreciate that the following description merely illustrates preferred embodiments of the invention, and that the invention can be practiced without one or more of these details. Furthermore, to avoid obscuring the invention, some technical features well-known in the art have not been described in detail.

[0031] An endoscopic ultrasound (EUS) is an endoscope equipped with ultrasound imaging capabilities. An EUS typically includes an insertion section, with an ultrasound probe located at the distal end. An instrument channel may be provided within the insertion section, through which medical instruments can pass to assist in diagnosis or treatment under ultrasound guidance. For ease of description, the term "distal" in this article refers to the end closer to the object being observed along the length axis of the insertion section of the EUS when the operator is using the endoscope; the term "proximal" or "base" refers to the end closer to the operator along the length axis of the insertion section of the EUS when the operator is using the endoscope.

[0032] Taking ultrasonic bronchoscopy as an example, it can be used to perform puncture procedures on the subject under ultrasound guidance. The medical device used can be a puncture assembly, which includes a sheath and a puncture needle, with the needle inserted inside the sheath. The ultrasonic bronchoscope may include a slender insertion section with a tip at its distal end. The tip may include a tip seat and an ultrasonic probe. An instrument channel may be provided within the insertion section, and a guide groove may be provided on the tip seat. The instrument channel can extend to the tip, through which the medical device can pass and extend into the guide groove. Guided by the guide groove, the medical device can extend a further distance to facilitate the manipulation of the subject. When using ultrasonic bronchoscopy, the ultrasonic probe is first placed against the bronchial wall to scan and determine the location of the puncture target. The puncture needle can be inserted into the sheath, and both can be inserted into the instrument channel together. With the ultrasound probe against the wall, the sheath is first extended into the guide groove to determine the position and direction of the puncture needle. To avoid the puncture needle hitting other structures on the tip or the ultrasound probe after extension, and to achieve a better puncture depth, the sheath typically needs to extend to the distal end of the guide groove. After the sheath is fully extended, the puncture needle inserted within the sheath can be extended to puncture the specimen.

[0033] However, in practical applications, it has been found that in some scenarios, especially when ultrasound images are obtained using the basal side region of the ultrasound probe's acoustic window, the ultrasound probe is prone to unstable contact with the wall during the above-mentioned puncture operation. This causes the operator to repeatedly adjust the position of the ultrasound probe to maintain contact with the wall, increasing the difficulty of the puncture operation.

[0034] In response to the above problems, the inventors of this application, after in-depth research and careful analysis, discovered that the root cause is as follows: In related technologies, since the distal end of the guide groove is basically flush with the proximal end of the acoustic window on the ultrasonic probe, when the sheath extends to the distal end of the guide groove, the distal part of the sheath protrudes from the guide groove and abuts against the bronchial wall. At this time, the bronchial wall will exert a reaction force on the sheath, forcing the sheath to move the guide groove, that is, to move the headstock away from the bronchial wall. Since the ultrasonic probe is connected to the distal end of the headstock, the headstock moving away from the bronchial wall will also move the ultrasonic probe away from the bronchial wall, making it difficult for the ultrasonic probe to maintain a stable wall-attached state, and the ultrasonic detection will be greatly affected.

[0035] In view of this, the present invention provides an ultrasonic endoscope and its tip. The ultrasonic endoscope and its tip provided in this application will be described in detail below with reference to specific embodiments.

[0036] See Figure 1The ultrasound endoscope 1 may include an insertion part 10 and an operating part 20, with the insertion part 10 connected to the operating part 20. The insertion part 10 may have a tip 11, a bend 12, and an insertion tube 13 arranged sequentially from distal to proximal. The insertion tube 13 may be connected to the operating part 20. The tip 11 may include a tip base 111 and an ultrasound probe 112. The ultrasound probe 112 may be connected to the distal end of the tip base 111, and the proximal end of the tip base 111 may be connected to the bend 12. (See also...) Figure 2 An instrument channel 14 may be provided within the insertion part 10. The proximal end of the instrument channel 14 may extend to the operating part 20, where an instrument channel inlet may be formed. The distal end of the instrument channel 14 may extend to the head end seat 111, where an instrument channel outlet may be formed. The head end seat 111 may be provided with a guide groove 1115, through which the instrument channel 14 can connect to the guide groove 1115. The medical device 30 may be inserted into the instrument channel 14 through the instrument channel inlet and extended into the guide groove 1115 through the instrument channel outlet, reaching the target location under the guidance of the guide groove 1115. The medical device 30 may include, for example, a puncture assembly comprising a sheath 31 and a puncture needle 32. When performing a puncture operation under ultrasound guidance, the sheath 31 may first pass through the instrument channel 14 and extend to a suitable position in the guide groove 1115, and then the puncture needle 32 may pass through the sheath 31 and extend to perform in vivo tissue puncture and biopsy. In the following embodiments, the medical device 30 includes a puncture assembly, which includes a sheath 31 and a puncture needle 32, as an example for description.

[0037] See Figure 3 , Figure 4 and Figure 5The head end portion 11 may include a head end base 111 and an ultrasound probe 112. The head end base 111 may have a proximal end portion 1111 and a distal end portion 1112 in a first direction (direction XX in the figure), where the first direction XX may be the axial direction of the head end base 111. The proximal end portion 1111 may include a portion of the head end base 111 near its proximal end, and the distal end portion 1112 may include a portion of the head end base 111 near its distal end. The proximal end portion 1111 and the distal end portion 1112 may be interconnected; for example, the distal end of the proximal end portion 1111 may be connected to the proximal end portion 1112. The proximal end portion 1111 and the distal end portion 1112 may be separate or integrally formed; the present invention does not specifically limit this. The figure shows the proximal side 1112a and the distal side 1112b of the distal end portion 1112, wherein the proximal side 1112a may be connected to the proximal end portion 1111, and the distal side 1112b may be connected to the ultrasound probe 112. The distal end portion 1112 may have a top 1113 and a bottom 1114 along the second direction (YY in the diagram), and the first direction XX may be perpendicular to the second direction YY. When the ultrasound probe 112 is in contact with the object to be examined, the top 1113 of the distal end portion 1112 may be located on the side of the distal end portion 1112 closer to the object to be examined along the second direction YY. In other words, the top 1113 of the distal end portion 1112 may be located on the side of the distal end portion 1112 facing the detection direction of the ultrasound probe 112. The bottom 1114 of the distal end portion 1112 may be located on the side of the distal end portion 1112 opposite to the top 1113 and further away from the object to be examined along the second direction YY. In other words, the bottom 1114 of the distal end portion 1112 may be located on the side of the distal end portion 1112 away from the detection direction of the ultrasound probe 112. The distal end 1112 may have a guide groove 1115 for discharging the medical device 30. The guide groove 1115 may have a groove end 1115a that is away from the proximal end 1111 and forms an outlet at the top 1113. The opening of the guide groove 1115 is located at the top 1113. The guide groove 1115 may extend from the proximal end 1111 toward the distal end 1112. The device channel outlet may be located on the proximal end 1111 and communicate with the guide groove 1115. The groove end 1115a may be formed on the guide groove 1115 at one end away from the proximal end 1111. Exemplarily, the proximal end 1111 may have a connecting surface 1111d, which may be connected to the distal end 1112. The device channel outlet may be located on the connecting surface 1111d. At this time, the guide groove 1115 can extend from the proximal end 1111 toward the distal end 1112, which can be considered as the guide groove 1115 extending from the connecting surface 1111d toward the distal side 1112b of the distal end 1112. An illumination module 1111b and a camera module 1111c can be provided on the proximal end 1111. For example, the illumination module 1111b and the camera module 1111c can be provided on the connecting surface 1111d.The end 1115a of the guide groove 1115 can be located within the field of view of the camera module 1111c, so that the distal end of the medical device 30 can appear in the camera's field of view before or when it extends out of the guide groove 1115, avoiding blind spots. Preferably, the camera module 1111c can be substantially coaxially arranged with the guide groove 1115, and multiple illumination modules 1111b can be symmetrically arranged on the proximal end 1111 about the guide groove 1115, for example, in... Figure 3 and Figure 4 In the illustrated embodiment, two illumination modules 1111b can be symmetrically arranged on the proximal end 1111 with respect to the camera module 1111c, thus providing better illumination uniformity from the two illumination modules 1111b. Depending on the form of the medical device 30 to be mounted, the guide groove 1115 can be designed in any suitable form. The extension length of the guide groove 1115 on the distal end 1112 can be any suitable length. In a plane parallel to the first direction XX and the second direction YY, the bottom of the guide groove 1115 can extend from the proximal end 1111 along any suitable path towards the distal side 1112b of the distal end 1112. Figure 2 In the illustrated embodiment, the bottom of the guide groove 1115 can be considered to extend along an arc path; in embodiments not shown, the guide groove 1115 may also extend along other curved paths.

[0038] See Figure 2 , Figure 3 , Figure 4 and Figure 5 An ultrasonic probe 112 can be connected to a distal side 1112b of a distal end portion 1112. The distal side 1112b of the distal end portion 1112 can be the side of the distal end portion 1112 away from the proximal end portion 1111; correspondingly, the distal end portion 1112 can also have a proximal side 1112a close to the proximal end portion 1111. The ultrasonic probe 112 can have an acoustic window 1121. An ultrasonic transducer can be disposed within the ultrasonic probe 112, and the ultrasonic transducer can perform detection on the object to be examined through the acoustic window 1121. Figure 2 In the illustrated embodiment, the detection area of ​​the ultrasonic probe 112 can be the region S shown in the figure. Of course, the detection area S in the illustrated embodiment is merely an example for illustrative purposes and is not intended to be limiting; the ultrasonic probe 112 and its corresponding detection area S can be arbitrary. Figure 2As shown, to ensure that the medical device 30, after being guided by the guide groove 1115, can reach the detection area S of the ultrasound probe 112, in the second direction YY, the bottom of the guide groove 1115 can gradually rise from its proximal end to its distal end 1115a (i.e., gradually moving away from the bottom 1114 of the distal end 1112), so as to guide the medical device 30 to deflect and extend in the second direction YY in a direction away from the bottom 1114 of the distal end 1112. The medical device 30 extending away from the bottom 1114 of the distal end 1112 can extend towards the object to be examined. The bottom of the guide groove 1115 can be raised along any suitable path, for example, in Figure 2 In the embodiment shown, the bottom of the guide groove 1115 can be raised along an arc path.

[0039] The acoustic window 1121 may have a base side 1122 near the distal end 1112, which can be considered as the proximal side of the acoustic window 1121. From the distal side 1112b of the distal end 1112 to the base side 1122 of the acoustic window 1121, in the second direction YY, there is a first feature portion that is furthest from the bottom 1114. The first feature portion is farther from the bottom 1114 than the groove end 1115a.

[0040] The first feature may be, for example, the base side 1122 of the acoustic window 1121. The base side 1122 of the acoustic window 1121 may be further away from the bottom 1114 than the end of the groove 1115a. The guide groove 1115 may be configured to allow the medical device 30 extending from the end of the groove 1115a to enter the detection area S of the ultrasound probe 112 without interference. Here, "far away from the bottom 1114" means that, in the second direction YY, the distance between the base side 1122 of the acoustic window 1121 and the bottom 1114 of the distal end 1112 is greater than the distance between the end of the groove 1115a and the bottom 1114 of the distal end 1112. See details. Figure 5 Since the base side 1122 of the acoustic window 1121 can be further away from the bottom 1114 than the end of the groove 1115a in the second direction YY, there can be a gap between the base side 1122 of the acoustic window 1121 and the end of the groove 1115a in the second direction YY. This gap can provide a space for the distal end of the medical device 30 extending to the end of the groove 1115a, thereby preventing the distal end of the medical device 30 from touching the subject and thus preventing the position of the ultrasound probe 112 from deviating.

[0041] See also Figure 2Taking the tip 11 applied to an ultrasonic endoscope 1 as an example, the ultrasonic endoscope 1 can be, for example, an ultrasonic bronchoscope. The medical device 30 can include a sheath 31 and a puncture needle 32. In the puncture operation of the ultrasonic bronchoscope, the puncture needle 32 is usually inserted into the sheath 31, passes through the instrument channel 14 through the sheath 31 and extends to a certain position in the guide groove 1115, and then passes through the sheath 31 and extends out. This can effectively prevent the puncture needle 32 from scratching or puncturing the inner wall of the instrument channel 14 when it passes through the curved and narrow instrument channel 14 independently, thereby effectively avoiding permanent damage to the ultrasonic endoscope 1 that may be caused by the puncture needle 32 directly and independently passing through the instrument channel 14. Moreover, the sheath 31 can stabilize and guide the extension of the puncture needle 32, thereby maintaining the puncture path and direction, ensuring that the puncture needle 32 will pierce the subject along the predetermined path when it extends, improving puncture accuracy, and preventing the puncture needle 32 from bending or deviating from the puncture path in the soft airway.

[0042] As the sheath 31 moves along the guide groove 1115, the bottom of the guide groove 1115 gradually rises in the second direction YY. When the sheath 31 reaches the end 1115a of the guide groove 1115, it is closest to the bronchial wall. Moreover, to obtain a better puncture angle and depth, the sheath 31 often needs to move to the end 1115a. At this time, since there is a gap between the base side 1122 of the acoustic window 1121 and the end 1115a in the second direction YY, this gap can accommodate the portion of the sheath 31 protruding from the end 1115a. This avoids the sheath 31 pressing against the bronchial wall when the acoustic window 1121 of the ultrasound probe 112 is completely against the wall or when it is against the wall near the base side 1122 of the acoustic window 1121, thus maintaining the stability of the acoustic window 1121 against the wall. This also avoids the sheath 31 pressing against the bronchial wall when the sheath 31 is located in other positions on the guide groove 1115.

[0043] See Figure 6 The ultrasonic probe 112 may have a protrusion 1123, which may be the portion of the ultrasonic probe 112 furthest from the bottom 1114 along the second direction YY. Exemplarily, the first feature may be the protrusion 1123 on the ultrasonic probe 112. Exemplarily, based on the fact that the base end side 1122 of the acoustic window 1121 is further away from the bottom 1114 of the distal end 1112 than the end of the groove 1115a, between the distal end side 1112b of the distal end 1112 and the base end side 1122 of the acoustic window 1121, the distance between the protrusion 1123 and the bottom 1114 in the second direction YY is greater than the distance between the base end side 1122 and the bottom 1114 of the acoustic window 1121. For ease of understanding, the distance difference is shown in the figure (distance a). Figure 6As shown, in the second direction YY, there is also a gap between the protrusion 1123 and the end of the groove 1115a, thus preventing the distal end of the sheath 31 from touching the object to be examined, thereby preventing the position of the ultrasound probe 112 from deviating. Since there is a distance 'a' between the protrusion 1123 and the base side 1122 of the acoustic window 1121 in the second direction YY, the gap between the protrusion 1123 and the end of the groove 1115a in the second direction YY can be larger, providing a larger accommodating space for the distal end of the medical device 30 extending to the end of the groove 1115a.

[0044] For example, see Figure 5 or Figure 6In the second direction YY, the distal side of the proximal end 1111 may have a second feature portion 1111a that is furthest from the bottom 1114. The distance between the second feature portion 1111a and the bottom 1114 is not less than the distance between the first feature portion (e.g., the base side 1122 of the acoustic window 1121) and the bottom 1114. For example, the distance between the second feature portion 1111a and the bottom 1114 may be equal to the distance between the first feature portion and the bottom 1114. Thus, the maximum outer diameter of the headstock 1111 can be substantially consistent with the outer diameter of the ultrasonic probe 112, facilitating the requirement for a smaller diameter. Alternatively, in some embodiments, the distance between the second feature portion 1111a and the bottom 1114 may also be greater than the distance between the first feature portion and the bottom 1114; that is, the second feature portion 1111a may be further away from the bottom 1114 than the first feature portion (e.g., the base side 1122 of the acoustic window 1121). The distal side of the proximal end 1111 may be provided with an instrument channel outlet, an illumination module 1111b and a camera module 1111c. On the distal side of the proximal end 1111, along the second direction YY, the second feature portion 1111a is farthest from the bottom 1114. That is to say, the second feature portion 1111a is farther from the bottom 1114 than both the illumination module 1111b and the camera module 1111c. Based on this, along the second direction YY, the second feature portion 1111a is further away from the bottom 1114 than the base side 1122 of the acoustic window 1121. The distal side of the proximal end portion 1111 has sufficient space in the second direction YY for setting the instrument channel outlet, the illumination module 1111b, and the camera module 1111c. Through reasonable design, for example, by setting the camera module 1111c at a suitable position on the distal side of the proximal end portion 1111, the obstruction of the imaging field of view of the ultrasound probe 112 on the camera module 1111c can be reduced, and / or the imaging field of view of the camera module 1111c can at least cover the end 1115a of the guide groove 1115. For a medical device 30 that passes through the instrument channel 14 and extends from the instrument channel outlet to the guide groove 1115, since the instrument channel outlet, the illumination module 1111b, and the camera module 1111c can be located on the proximal end 1111, at least the end 1115a of the guide groove 1115 can be located within the imaging field of view of the camera module 1111c. This facilitates the appearance of the medical device 30 in the imaging image of the ultrasound endoscope 1, thereby reducing the instrument blind zone. Preferably, the guide groove 1115 can be located within the imaging field of view of the camera module 1111c, so that the medical device 30 extending into the guide groove 1115 can appear in the optical image acquired by the camera module 1111c. In addition, the second feature portion 1111a is further away from the bottom 1114 than the base side 1122 of the acoustic window 1121, which further ensures that the medical device 30 located at any position on the guide groove 1115 will not abut against the subject.

[0045] For example, see Figure 2 , Figure 5 and Figure 6 On a projection plane parallel to the first direction XX and parallel to the second direction YY, there is a gap (distance d) between the line connecting the first feature portion (e.g., the base end side 1122 of the acoustic window 1121) and the second feature portion 1111a (the line P shown in the figure) and the end of the groove 1115a. The projection plane parallel to the first direction XX and parallel to the second direction YY mentioned here can be parallel to the obtained... Figure 2 The cross-sectional plane shown in the sectional view. When the head end 11 is in use, taking the acoustic window 1121 of the ultrasound probe 112 as an example where it is completely attached to the wall, the line P connecting the first feature portion (e.g., the base side 1122 of the acoustic window 1121) and the second feature portion 1111a can be the line that may be attached to the wall at this time. It can be considered that as long as it does not exceed the line P, it can avoid touching the object to be examined. Therefore, when there is a gap d between the line P connecting the first feature portion (e.g., the base side 1122 of the acoustic window 1121) and the second feature portion 1111a and the end of the groove 1115a, the space corresponding to the gap d can provide a accommodating space for the medical device 30, for example, it can provide a accommodating space for the sheath 31. The edge of the distal end of the sheath 31 located on the guide groove 1115 can not exceed the line P, thereby avoiding the distal end of the sheath 31 on the guide groove 1115 from touching the object to be examined, thus making the ultrasound probe 112 more stably attached to the bronchial wall, and making the detection effect of the ultrasound probe 112 better.

[0046] For example, the spacing d can be 0.5mm to 2mm, such as 0.5mm, 0.7mm, 1.3mm, 1.6mm or 2mm. If the spacing d is too small, the space corresponding to the spacing d cannot accommodate the medical device 30 extending to the end of the groove 1115a; if the spacing d is too large, it will be difficult for the medical device 30 to reach the target position. For example, when the medical device 30 includes a sheath 31 and a puncture needle 32, with an excessively large spacing d, the puncture needle 32 may be blocked by the ultrasound probe 112 when it extends out of the sheath 31. In order to avoid the ultrasound probe 112 forming an obstruction, the guide groove 1115 needs to be designed to have a larger lifting angle. This will result in the overlap between the area where the puncture needle 32 can perform the puncture operation and the detection area S of the ultrasound probe 112 being too small. On the other hand, it will result in the puncture needle 32 having an excessively large angle when puncturing the specimen, making it impossible to achieve wall-mounted puncture. When the spacing d is 0.5mm to 2mm, it can be adapted to most sheath tube 31 sizes. For example, the diameter of the sheath tube 31 is usually no more than 1.8mm. Such a spacing d can also be adapted to most sheath tubes 31. Moreover, for such a spacing d, not only is the space corresponding to the spacing d sufficient to accommodate the sheath tube 31 extending to the end of the groove 1115a, but the ultrasonic probe 112 will not obstruct the extension of the puncture needle 32.

[0047] The proximal end portion 11 of the present invention has a guide groove 1115 formed on its distal end portion 1112. The guide groove 1115 can guide the extension of the medical device 30. Since the portion from the distal end side 1112b of the distal end portion 1112 to the base end side 1122 of the acoustic window 1121 has a first feature portion farthest from the bottom 1114 in the second direction YY, the first feature portion is farther away from the bottom 1114 than the groove end portion 1115a, thus there is a gap between the first feature portion and the groove end portion 1115a; in the second direction, the distal end of the proximal end portion 1111... Side 1112b has a second feature portion 1111a furthest from the bottom 1114. The distance between the second feature portion 1111a and the bottom 1114 is not less than the distance between the first feature portion and the bottom 1114. Therefore, on a projection plane parallel to the first direction XX and parallel to the second direction YY, there is a gap between the line connecting the first feature portion and the second feature portion 1111a and the end of the groove 1115a. Thus, when the base end side 1122 of the acoustic window 1121 of the ultrasonic probe 112 is in contact with the object to be examined, for example, when it is in contact with the bronchial wall... The gap between the line connecting the first feature portion and the second feature portion 1111a and the end 1115a of the guide groove 1115 can provide a space for the distal end of the medical device 30 extending to the end 1115a of the groove. For example, during a puncture procedure, it can provide a space for the distal end of the sheath 31. This prevents the acoustic window 1121 of the ultrasound probe 112 from being blocked by the medical device 30 (sheath 31) on the guide groove 1115 when it is against the subject. 21 is moved away from the object to be examined, so that the ultrasonic probe 112 is stably attached to the object to be examined, so that the detection effect of the ultrasonic probe 112 can be better; when the spacing is 0.5mm~2mm, it can be adapted to most sheath tube 31 sizes. For example, the diameter of the sheath tube 31 is usually no more than 1.8mm, so such a spacing can be adapted to most sheath tubes 31. Moreover, for such a spacing, not only is the space corresponding to the spacing sufficient to accommodate the sheath tube 31 extending to the end of the groove 1115a, but the ultrasonic probe 112 will not obstruct the extension of the puncture needle 32.

[0048] In one embodiment of the present invention, see Figure 3 , Figure 4 , Figure 7 and Figure 8Along the first direction XX, there may be a gap between the end of the groove 1115a and the ultrasonic probe 112. Since the base side 1122 of the acoustic window 1121 is farther from the bottom 1114 of the distal end 1112 than the end of the groove 1115a in the second direction YY, in order to avoid the portion of the ultrasonic probe 112 located between the base side 1122 of the acoustic window 1121 and the distal end 1112 obstructing the extension of the medical device 30, there may be a gap between the end of the groove 1115a and the ultrasonic probe 112 in the first direction XX. For example, when the medical device 30 includes a sheath 31 and a puncture needle 32, the sheath 31 can be mounted on a guide groove 1115. After the puncture needle 32 passes through the sheath 31, it needs to be inserted into the detection area S of the ultrasound probe 112 to perform in vivo tissue puncture and biopsy. At this time, since the sheath 31 mounted on the guide groove 1115 can be tilted and raised, and there is a gap between the end of the groove 1115a and the ultrasound probe 112 along the first direction XX, the puncture needle 32 passing through the sheath 31 can also use the gap between the end of the groove 1115a and the ultrasound probe 112 to gradually move away from the bottom 1114 of the distal end 1112, thereby avoiding the portion of the ultrasound probe 112 located between the base side 1122 of the acoustic window 1121 and the distal side 1112b of the distal end 1112 blocking the puncture needle 32. In other words, when there is a gap between the end 1115a of the groove along the first direction XX and the ultrasound probe 112, it is not necessary to increase the deflection angle of the puncture needle 32 to avoid the base side 1122 of the acoustic window 1121, that is, to avoid the ultrasound probe 112. This makes it easier for the medical device 30 mounted on the guide groove 1115 to extend into the detection area S of the ultrasound probe 112, and allows the puncture needle 32 to maintain a better puncture angle and puncture depth.

[0049] In one embodiment of the present invention, see Figure 5 The first feature can be the base side 1122 of the acoustic window 1121. Between the base side 1122 and the distal end 1112 of the acoustic window 1121, the base side 1122 of the acoustic window 1121 is furthest from the bottom 1114 in the second direction YY. This means that in the portion of the ultrasonic probe 112 located between the base side 1122 and the distal end 1112 of the acoustic window 1121, there can be no unnecessary parts other than the necessary connecting structures. In other words, the base side 1122 of the acoustic window 1121 can be positioned as close as possible to the distal end 1112 on the ultrasonic probe 112. This fully utilizes the structural space along the first direction XX on the ultrasonic probe 112, reduces space waste, and facilitates a more compact overall structure.

[0050] For example, see Figure 2 , Figure 3 , Figure 4 , Figure 5 and Figure 6The head end 11 may also include a camera module 1111c, which may be disposed on the connection surface 1111d of the proximal side 1112a connecting the second feature part 1111a and the distal end 1112, and the groove end 1115a may be located within the field of view of the camera module 1111c. Taking the medical device 30, which includes a sheath 31 and a puncture needle 32, as an example, after the medical device 30 extends to the end of the groove 1115a, when it extends further, for example, after the sheath 31 extends to the end of the groove 1115a, the puncture needle 32 extends further from inside the sheath 31, allowing for puncture of the specimen. At this time, the puncture needle 32 can be located within the detection area S of the ultrasound probe 112. Before the puncture needle 32 enters the detection area S of the ultrasound probe 112, since the end of the groove 1115a can be located within the field of view of the camera module 1111c, the puncture needle 32 is located within the field of view of the camera module 1111c as it extends from the sheath 31. This facilitates the use of various imaging methods to determine the position of the puncture needle 32, which helps guide subsequent operations. In other words, the end of the groove 1115a being within the field of view of the camera module 1111c makes it easier to observe and determine the position of the medical device 30, thus facilitating subsequent operations.

[0051] For example, see see Figure 7 and Figure 8 The medical device 30 may include a sheath 31 and a puncture needle 32 inserted within the sheath 31. A mark 1116 may be provided on the top 1113 next to the guide groove 1115. The mark 1116 may be located within the field of view of the camera module 1111c to indicate the recommended exit position of the puncture needle 32. Specifically, the exit position of the puncture needle 32 is the position of the distal end of the sheath 31 on the guide groove 1115 when the puncture needle 32 extends out of the sheath 31. The recommended exit position of the puncture needle 32 is the recommended exit position of the puncture needle 32. When the base side 1122 of the acoustic window 1121 is against the cavity wall, the distal end of the sheath 31 extends to the recommended exit position corresponding to the mark 1116. The distal end of the sheath 31 will not abut against the subject, and after the puncture needle 32 extends out of the sheath 31 from the recommended exit position, it can also enter the detection area S of the ultrasound probe 112 without interference. This further prevents the sheath 32 from touching the subject and improves the convenience of the puncture procedure.

[0052] The recommended export position is not limited to one or several specific locations; it can also be understood as a region. When the sheath 31 moves within the region corresponding to the recommended export position, it will not come into contact with the object to be examined. For example, mark 1116 can indirectly guide the distal position of the sheath 31. Mark 1116 can be used to indicate the distance in the second direction YY between the sheath 31 at the position corresponding to mark 1116 on the guide groove 1115 and the base end side 1122 of the acoustic window 1121. For a sheath 31 of a certain size, when the sheath 31 is located at different positions on the guide groove 1115, the distance in the second direction YY between the sheath 31 and the base end side 1122 of the acoustic window 1121 can be calculated in advance. This calculated distance can then be recorded at mark 1116 to provide guidance to the operator. By referring to the distance between the base side 1122 of the reference sheath 31 and the acoustic window 1121 in the second direction YY, the approximate distance between the sheath 31 and the object to be examined can be determined, thus allowing operation to continue without the sheath 31 touching the object to be examined. Multiple marks 1116 can be provided on the side of the guide groove 1115; the specific number can be designed according to actual conditions. Furthermore, it is not required to record specific numbers at the marks 1116; the marks 1116 can be horizontal lines or other suitable patterns. When the proximal end 1111 is provided with an illumination module 1111b and a camera module 1111c, the guide groove 1115 and the sheath 31 mounted on it can be observed, and the top 1113 of the distal end 1112 can also be observed. By comparing the position of the sheath 31 with the marks 1116, the distance between the sheath 31 and the object to be examined in the second direction YY can be determined. Mark 1116 can also directly guide the distal position of the sheath 31. Taking a long strip extending along the length axis of the headstock 111 as an example, when the sheath 31 moves in the area corresponding to the mark 1116 on the guide groove 1115, it can ensure that the sheath 31 will not come into contact with the subject. In this way, the mark 1116 can provide a prompt for the distal position of the sheath 31. Of course, the mark 1116 can be any suitable form other than a long strip. For example, the mark 1116 can be multiple horizontal lines. When the sheath 31 moves in the area corresponding to the multiple horizontal lines on the guide groove 1115, it will not come into contact with the subject. Furthermore, when the distal end of the sheath 31 is located in this area, the puncture needle 32 can also extend from the sheath 31 and enter the detection area S of the ultrasound probe 112 without interference.

[0053] For example, see Figure 7 and Figure 8The markings 1116 can be set in pairs, and a pair of markings 1116 can be symmetrically set about the guide groove 1115. When a pair of markings 1116 are symmetrically set on both sides of the guide groove 1115, they are more conspicuous, and the markings 1116 can better indicate the relative position of the sheath 31. In addition, such a tip 11 can also be more suitable for medical devices 30 with asymmetrical structures, thus broadening the applicability of the tip 11.

[0054] For example, see Figure 7 and Figure 8 The marker 1116 and the second feature portion 1111a can have a first distance L1 in the first direction XX, and the base end side 1122 of the acoustic window 1121 and the second feature portion 1111a can have a second distance L2 in the first direction XX. The first distance L1 and the second distance L2 can satisfy... . If the exit position of the puncture needle 32, as indicated by the mark 1116, is too close to the proximal end 1111 and too far from the distal end 1112b of the distal end 1112, the lifting effect of the guide groove 1115 on the puncture needle 32 is limited when the puncture needle 32 extends from the sheath 31 at this position. This results in an excessively small deflection angle of the puncture needle 32. Continuing to extend it may cause interference with the subsequent part on the guide groove 1115 or the ultrasound probe 112, thereby damaging the relevant structures. At this time, if the marker 1116 is too close to the base side 1122 of the acoustic window 1121, the indication effect for the medical device 30 moving on the guide groove 1115 will be poor. Preferably, The first distance L1 and the second distance L2 satisfy... At this time, the mark 1116 is at a certain distance from the proximal end 1111 and also at a certain distance from the base side 1122 of the acoustic window 1121. Based on the good indication effect of the mark 1116, the recommended exit position indicated by the mark 1116 can not only avoid the ultrasound probe 112 from blocking the continued extension of the puncture needle 32 after the puncture needle 32 is exited at the recommended exit position, but also further ensure that the sheath 31 will not touch the subject when it is in the recommended exit position.

[0055] For example, see Figure 7 and Figure 8The mark 1116 and the second feature 1111a can have a first distance L1 in the first direction XX. The first distance L1 can be 2mm to 6mm, for example, the first distance L1 can be 2mm, 2.4mm, 3.7mm, 4.8mm or 6mm. Preferably, the first distance L1 can be 4mm. When the first distance L1 is 2mm to 6mm, the mark 1116 can promptly indicate the distal position of the sheath 31, which is convenient to keep the sheath 31 contained in the interval along the second direction YY between the base end side 1122 of the acoustic window 1121 and the end of the groove 1115a during operation, thereby better preventing the sheath 31 from touching the object to be inspected.

[0056] According to another aspect of the present invention, an ultrasonic endoscope 1 is provided. The ultrasonic endoscope 1 includes an insertion portion 10, which includes any of the tip portions 11 described above. Since the tip portion 11 described above has the aforementioned beneficial effects, the ultrasonic endoscope 1 including the tip portion 11 described above also has the aforementioned beneficial effects, which will not be repeated here.

[0057] In the description of this invention, it should be understood that the orientation or positional relationship indicated by directional terms such as "front", "rear", "up", "down", "left", "right", "horizontal", "vertical", "horizontal", "top", and "bottom" is generally based on the orientation or positional relationship shown in the accompanying drawings and is only for the convenience of describing this invention and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the scope of protection of this invention; the directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.

[0058] For ease of description, relative terms such as "above," "over," "on the upper surface of," and "above" are used here to describe the regional positional relationship of one or more components or features shown in the figures to other components or features. It should be understood that relative terms include not only the orientation of the component as depicted in the figure but also different orientations during use or operation. For example, if the components in the figures are inverted as a whole, "above" or "above other components or features" will include cases where the component is "below" or "under" other components or features. Thus, the exemplary term "above" can include both "above" and "below." Furthermore, these components or features may also be positioned at other different angles (e.g., rotated 90 degrees or other angles), and this document intends to include all such cases.

[0059] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms “comprising” and / or “including” are used in this specification, they indicate the presence of features, steps, operations, parts, components, and / or combinations thereof.

[0060] It should be noted that the terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in sequences other than those illustrated or described herein.

[0061] The present invention has been described through the above embodiments. However, it should be understood that the above embodiments are for illustrative purposes only and are not intended to limit the invention to the scope of the described embodiments. Furthermore, those skilled in the art will understand that the present invention is not limited to the above embodiments, and many more variations and modifications can be made based on the teachings of the present invention, all of which fall within the scope of protection claimed by the present invention. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A tip of an ultrasonic endoscope, characterized in that, Includes head mount and ultrasound probe, The head end has a proximal end and a distal end in a first direction, the first direction being the axial direction of the head end; the distal end has a top and a bottom along a second direction, the first direction being perpendicular to the second direction; the distal end is formed with a guide groove for discharging a medical device; the guide groove has a groove end that is away from the proximal end and forms an outlet at the top. The ultrasound probe is connected to the distal end of the distal end, and the ultrasound probe is a sector scan ultrasound probe. The ultrasound probe has an acoustic window, and the acoustic window has a base end side near the distal end. Wherein, from the distal end side of the distal end to the base end side of the acoustic window, in the second direction, there is a first feature portion that is furthest from the bottom, and the first feature portion is farther away from the bottom than the end of the groove; Along the first direction, there is a gap between the end of the groove and the ultrasonic probe; In the second direction, the distal side of the proximal end has a second feature portion that is furthest from the bottom, and the distance between the second feature portion and the bottom is greater than the distance between the first feature portion and the bottom; On a projection plane parallel to the first direction and parallel to the second direction, there is a gap between the line connecting the first feature and the second feature and the end of the groove, the gap being 0.5mm to 2mm.

2. The head end portion according to claim 1, characterized in that, The first feature is the base end side of the acoustic window.

3. The head end portion according to claim 1, characterized in that, The head end also includes a camera module, which is disposed on the connection surface connecting the second feature part and the distal end, and the end of the groove is located within the field of view of the camera module.

4. The head end portion according to claim 3, characterized in that, The medical device includes a sheath and a puncture needle inserted inside the sheath; a mark is provided on the top of the device next to the guide groove, the mark being located within the field of view of the camera module, for indicating the recommended exit position of the puncture needle.

5. The head end portion according to claim 4, characterized in that, The markers are arranged in pairs, and the pair of markers are symmetrically arranged about the guide slot.

6. The head end portion according to claim 4, characterized in that, The mark and the second feature portion are separated by a first distance L1 in the first direction, and the base end of the acoustic window and the second feature portion are separated by a second distance L2 in the first direction. The first distance L1 and the second distance L2 satisfy... .

7. The head end portion according to claim 4, characterized in that, The mark and the second feature portion are separated by a first distance L1 in the first direction, and the first distance L1 is 2mm to 6mm.

8. The head end portion according to any one of claims 1-7, characterized in that, The ultrasonic endoscope is an ultrasonic bronchoscope.

9. An ultrasonic endoscope, characterized in that, It includes an insertion portion, the insertion portion including a head end portion as described in any one of claims 1-8.

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